Hydro Ear News

SATURDAY, July 18, 2015 – If your child develops an itchy rash, it could be hives, experts say. Common symptoms of hives – which are usually temporary and harmless – include: slightly raised, pink or red areas on the skin; welts that occur alone, in a group, or that connect over a large area; and skin swelling, according to the American Academy of Dermatology (AAD). Hives can be triggered by a wide variety of things, including allergic reactions to food or medication, infections, exercise, stress, cold temperatures, insect bites and stings, pollen, sun exposure and scratching the skin. "The best remedy for hives is to try to avoid whatever triggers them, although identifying this is often difficult," Dr. Bruce Brod, a clinical professor of dermatology at University of Pennsylvania in Philadelphia, said in an AAD news release. "One way to help identify your triggers is to keep a log ... Read more

ISSUE: FDA announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status. Unapproved prescription otic drug products are frequently given to young children suffering from ear infections and other conditions that cause ear pain and swelling. Patients taking unapproved drugs may be at greater risk because there is no proven safety or effectiveness information. These products may be ... Read more

July 1, 2015 – The U.S. Food and Drug Administration today announced its intention to take enforcement action against companies that manufacture and/or distribute certain unapproved prescription ear drop products (known as otic products) labeled to relieve ear pain, infection, and inflammation. The unapproved prescription ear drops contain active ingredients such as benzocaine and hydrocortisone, and have not been evaluated by the FDA for safety, effectiveness and quality. The labels on these products do not disclose that they lack FDA approval, and health care professionals may not be aware of their unapproved status. In a federal register notice published today, the agency informed the companies that they must stop manufacturing these unapproved prescription otic products or be subject to enforcement actions, including seizure, injunction and/or criminal proceedings. Today’s action ... Read more

WEDNESDAY, July 1, 2015 – The prescription drops your child is using for ear pain could be among 16 unapproved medications targeted this week by the U.S. Food and Drug Administration. These drugs, prescribed and sold for years to relieve ear pain and swelling, have not been evaluated for safety, quality and effectiveness, the agency said Wednesday. The agency notified the drugs' makers to stop marketing the drops following a few reports of local allergic reactions of the ear, eye, face, neck and mouth. The drops can also cause itching, stinging, burning and irritation of the ear, according to an FDA news release. "If we don't know whether these drugs have any benefits, we should not accept any possible risk of side effects," said the FDA's Dr. Charles Lee in the news release. The FDA did not release the names of the companies or the medications involved, but did note that "unapproved ... Read more